EMA releases revised guidance on EU Periodic-Safety-Update-Report Single Assessment for Nationally Authorised Medicines

The revised procedural guidance European Medicines Agency Post-Authorisation Procedural Advice for Users of the Centralised Procedure is intended “to ensure that Marketing-Authorization Holders (MAHs) are prepared for the submission of Periodic Safety Update Reports (PSURs) for nationally authorized medicines subject to European Union single assessment.”

PSURs provide a comprehensive and critical analysis of the risk-benefit balance of a medicinal product, submitted by MAHs at defined time points during the post-authorization phase. The single assessment of nationally authorized medicines “aims to harmonize and strengthen the review of the benefits and risks of all medicines across the EU.” The Pharmacovigilance Risk Assessment Committee (PRAC) issues a recommendation for all EU PSUR single assessments (PSUSA).

The following information briefly outlines the procedures and responsibilities of MAHs with nationally authorized medicines subject to EU single assessment:

  • They must submit PSURs to the EMA and all Member States where their medicine is authorized. This applies to all medicines with data lock points falling on or after September 1, 2014.
  • These PSURs will be assessed by the PRAC or a Member State appointed by the CMDh, and one single assessment report will be generated. This report is then shared amongst all MAHs whose medicinal products are part of the PSUSA procedure.
  • The dates and frequency of submission of the PSUR have been listed in the EU reference dates (EURDs).
  • “For all EU PSUSA procedures starting October 2014, the procedure number will be published in advance in the EURD list. MAHs should therefore include their procedure number when preparing their submission.”
  • “MAHs of nationally authorized products should also complete Annex I of the formatted table template of the cover letter.”
  • “The PSUR timetable has also been integrated with the PSUR single-assessment procedures containing nationally authorized medicinal products.”
  • MAHs have to pay a fee for assessment of PSURs as of August 26, 2014.

Pages 142 through 158 of the revised guidance further clarifies the procedures concerning the submission of PSURs and outlines the responsibilities of all parties involved in the process.

The EMA guidance press release can be accessed here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/08/news_detail_002160.jsp&mid=WC0b01ac058004d5c1

The full revised guidance can be accessed here:
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf

Glossary
MAHs – Marketing Authorisation Holders
PSURs – Periodic Safety Update Reports
PSUSA – Periodic Safety Update Reports Single Assessments
CMDh – Coordination Group for Mutual Recognition and Decentralised Procedures – Human
PRAC – Pharmacovigilance Risk Assessment Committee

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